A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

This study has been completed.

Sponsor:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01379534

First Posted: June 23, 2011

Last Update Posted: May 20, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Outcome Measures:

Overall Response Rate (ORR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]

ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).

Disease Control Rate (DCR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]

DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).

Duration of Response (DR) [ Time Frame: up to 18 weeks ]

Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.

Overall Survival (OS) [ Time Frame: up to 18 weeks ]

OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.

Progression Free Survival (PFS) [ Time Frame: up to 18 weeks ]

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.

Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: up to 30 days after the last dose of study drug, up to 18 weeks ]

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